This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for updating the safety alert from a caution to a warning in the instructions for use for the frx and fr3 infant/child keys
| Device | HeartStart FR3 Defibrillator |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. |
| Date Received | 2021-05-17 |
| Decision Date | 2021-06-15 |
| PMA | P160028 |
| Supplement | S004 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PHILIPS MEDICAL SYSTEMS, INC. 22100 Bothell Everett Highway bothell, WA 98021 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160028 | Original Filing | |
| S004 | 2021-05-17 | Special (immediate Track) |
| S003 | 2020-11-16 | 30-day Notice |
| S002 | ||
| S001 | 2020-07-06 | 30-day Notice |